Hepatoprotective Effects of Reishi Mushroom- (Ganoderma Lucidum) Among Metabolic Dysfunction-associated Fatty Liver Disease Patients
Recruiting · NCT07534241 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Lahore
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboReishi mushroom dried powderreishi mushroom- (Ganoderma lucidum)
What this trial is about
This 12-week RCT investigates the hepatoprotective and immunomodulatory effects of Ganoderma lucidum combined with a probiotic-rich diet in adults with MAFLD, assessing liver enzymes, lipid profile, inflammation, gut microbiota, and oxidative stress. Findings are expected to show dose-dependent improvements in hepatic fat, insulin resistance, and inflammatory markers, potentially reducing reliance on pharmacotherapy in
Who can take part
Age range
35 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Adults aged 35-65 years
- BMI between 18.5 and 30 kg/m².
- Complete Blood Count test ranges, WBC \< 4,000-11,000 cells/µL, RBC Men \< 4.5-6.0 / Women 4.0-5.5 million/µL, Hemoglobin: Men \< 13.5-17.5 / Women 12.0-15.5 g/dL, Platelets \< 150,000-450,000 cells/µL.
- Lipid profile test markers (elevated LDL, total cholesterol, or triglycerides less than 150mg/dL high 200-499mg/dL and 500 mg/dL are above high.
- Liver function test markers, ALT \> 56 U/L, AST\>40 U/L, ALP\>147 UL.
- Inflammatory markers: CRP \>3 mg/L, - IL-6 ≥3 pg/mL, TNF-α ≥8 pg/mL.
- Elevated blood sugar levels, or hyperglycemia, refer to a typically above 126 mg/dL, fasting or 200 mg/dL post-meal.
Exclusion criteria
- ● Diagnosed with severe cardiovascular disease, liver failure, or renal impairment.
- Pregnant or lactating women.
- Individuals currently on statins, ezetimibe, PCSK9 inhibitors, or any other lipid-lowering therapy.
- Allergic to mushrooms.
- Diagnosed with celiac disease or other chronic gastrointestinal disorders (e.g., Crohn's disease, ulcerative colitis).
- History of malignancy.
- Participation in another clinical trial within the last 3 months.
Where it is running
1 location listed.
- Sana Noreen - Lahore, Pakistan